• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.131-136
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• 2006

The purpose of the present study was to evaluate the bioequivalence of two losartan tablets, $Cozaar^{TM}$ tablet (MSD Korea. Co., Ltd., Seoul, Korea, reference drug) and $Losartan^{TM}$ tablet (DaeWon Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the losartan kalium dose of 100 mg in a $2\;{\time}\;2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of losartan were monitored by an LC-MS/MS for over a period of 12 hr after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Cozaar^{TM}/Losartan^{TM}$ were $log\;0.97{\sim}log\;1.12\;and\;log\;0.93{\sim}log\;1.23$, respectively. These values were within the acceptable bioequivalence intervals of $log\;0.80{\sim}log\;1.25$. Taken together, our study demonstrated the bioequivalence of $Cozaar^{TM}$ and $Losartan^TM$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.29 no.2
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• pp.145-149
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• 1999

Bioequivalence of two cefixime capsules, test drug ($Cepirin^R$ capsule: Cheiljedang Corp.) and reference drug ($Suprax^R$ capsule: Dong A Pharm. Com.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered the drug orally at the dose of 400 mg as cefixime in a $2{\times}2$ crossover study. There was a 1-week washout period between the administrations. Blood samples were taken at predetermined time intervals for 12 hour and the plasma concentration of cefixime was determined with a HPLC method. $AUC_{0-12hr}$ (area under the plasma concentration-time curve form time zero to 12 hour), $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were estimated from the plasma drug concentrationtime data. Analysis of variance (ANOVA) revealed no difference in $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences of these parameters between the formulations were less than 20% (i.e., 8.62, 11.10 and 0.00% for $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$,respectively). The powers $(1-{\beta})$ for $AUC_{0-12hr}$ $C_{max}$ and $T_{max}$ were over 0.9. Minimal detectable difference $({\Delta})$ at ${\alpha}=0.05$, $1-{\beta}=0.8$ were less than 20% (i.e., 12.84, 11.05 and 17.99% for $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals $({\delta})$ for these parameters were also within ${\pm}20%$ (i.e., $-0.53{\le}{\delta}{\le}17.76$, $3.23{\le}{\delta}{\le}18.97$ and $-12.81{\le}{\delta}{\le}12.81$ for $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$, respectively). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating the two formulations of cefixime were bioequivlent.

• Journal of Pharmaceutical Investigation
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• v.37 no.4
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• pp.255-261
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• 2007

A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 hr) was calculated by the linear trapezoidal rule method. $C_{MAX}$ (maximum plasma drug concentration) and $T_{MAX}$ (time to reach $C_{MAX}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t\;and\;C_{MAX}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{MAX}$ ratio for $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.

• Journal of Korean Neurosurgical Society
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• v.42 no.3
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• pp.200-204
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• 2007

Objective : Radiation therapy is an important treatment for brain tumor. However, serious complications such as radiation necrosis can occur and it may be secondary to the expression of acute phase genes, like cytokines. In particular, inflammatory cytokines (IL-$1{\beta}$, TNF-${\alpha}$) and other immunomodulatory cytokines (TNF-${\alpha}$, TGF-${\beta}1$) might be changed after irradiation (high single dose irradiation). Although it has been reported that IL-1 level is remarkably elevated within 8 week after the irradiation to the rat brain. the change of cytokines levels at acute phase (within 24 hours) has not been reported. In the present study, we examined TNF-${\alpha}$, TGF-${\beta}1$, and IL-$1{\beta}$ levels in acute phase to clarify the early effect of cytokines on the radiation-induced brain damage. Methods : Fifty Sprague-Dawley rats were used and these were divided into irradiation group and control group. After a burr-hole trephination on the right parietal area using a drill, a single 10Gy was irradiated at the trephined site. Their forebrains were extirpated at 30 min, 2 hr, 8 hr, 12 hr and 24 hr, respectively and examined for the expression of TNF-${\alpha}$, TGF-${\beta}1$, and IL-$1{\beta}$. Results : The expression of TNF-${\alpha}$ and TGF-${\beta}1$ were decreased until 12 hr after irradiation but elevated thereafter. The expression of IL-1 was peak at 8 hr and then decreased until 12 hr but elevated after this time window. The present study indicated that expression of cytokines (TNF-${\alpha}$, TGF-${\beta}1$ and IL-$1{\beta}$) were increased at 24 hr after the irradiation to the rat brain. IL-$1{\beta}$ level, on the other hand. reached peak at 8 hr after radiation injury. Conclusion : These findings indicate that IL-1, among various cytokines, may have a more important role in the inflammatory reaction by radiation injury at acute phase and provide some clues for better understanding of the pathogenesis of radiation injury.

• The Korean Journal of Physiology and Pharmacology
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• v.22 no.1
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• pp.35-42
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• 2018

Ascorbic acid is one of the most well-known nutritional supplement and antioxidant found in fruits and vegetables. Calcium ascorbate has been developed to mitigate the gastric irritation caused by the acidity of ascorbic acid. The aim of this study was to compare calcium ascorbate and ascorbic acid, focusing on their antioxidant activity and effects on gastric juice pH, total acid output, and pepsin secretion in an in vivo rat model, as well as pharmacokinetic parameters. Calcium ascorbate and ascorbic acid had similar antioxidant activity. However, the gastric fluid pH was increased by calcium ascorbate, whereas total acid output was increased by ascorbic acid. In the rat pylorus ligation-induced ulcer model, calcium ascorbate increased the gastric fluid pH without changing the total acid output. Administration of calcium ascorbate to rats given a single oral dose of 100 mg/kg as ascorbic acid resulted in higher plasma concentrations than that from ascorbic acid alone. The area under the curve (AUC) values of calcium ascorbate were 1.5-fold higher than those of ascorbic acid, and the $C_{max}$ value of calcium ascorbate (91.0 ng/ml) was higher than that of ascorbic acid (74.8 ng/ml). However, their $T_{max}$ values were similar. Thus, although calcium ascorbate showed equivalent antioxidant activity to ascorbic acid, it could attenuate the gastric high acidity caused by ascorbic acid, making it suitable for consideration of use to improve the side effects of ascorbic acid. Furthermore, calcium ascorbate could be an appropriate antioxidant substrate, with increased oral bioavailability, for patients with gastrointestinal disorders.

• Journal of Korean Society of Water and Wastewater
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• v.31 no.6
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• pp.501-510
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• 2017

In this study, it is estimated that ceramic membrane process which can operate stably in harsh conditions replacing existing organic membrane connected with coagulation, sedimentation etc.. Jar-test was conducted by using artificial raw water containing kaolin and humic acid. It was observed that coagulant (A-PAC, 10.6%) 4mg/l is the optimal dose. As a results of evaluation of membrane single filtration process (A), coagulation-membrane filtration process (B) and coagulation-sedimentation-membrane filtration process (C), TMP variation is stable regardless of in Flux $2m^3/m^2{\cdot}day$. But in Flux $5m^3/m^2{\cdot}day$, it show change of 1-89.3 kpa by process. TMP of process (B) and (C) is increased 11.8, 0.6 kpa each. But, the (A) showed the greatest change of TMP. When evaluate (A) and (C) in Flux $10m^3/m^2{\cdot}day$, TMP of (A) stopped operation being exceeded 120 kpa in 20 minutes. On the other hand, TMP of (C) is increased only 3 kpa in 120 minutes. Through this, membrane filtration process can be operated stably by using the linkage between the pretreatment process and the ceramic membrane filtration process. Turbidity of treated water remained under 0.1 NTU regardless of flux condition and DOC and $UV_{254}$ showed a removal rate of 65-85%, 95% more each at process connected with pretreatment. Physical cleaning was carried out using water and air of 500kpa to show the recovery of pollutants formed on membrane surface by filtration. In (A) process, TMP has increased rapidly and decreased the recovery by physical cleaning as the flux rises. This means that contamination on membrane surface is irreversible fouling difficult to recover by using physical cleaning. Process (B) and (C) are observed high recovery rate of 60% more in high flux and especially recovery rate of process (B) is the highest at 95.8%. This can be judged that the coagulation flocs in the raw water formed cake layer with irreversible fouling and are favorable to physical cleaning. As a result of estimation, observe that ceramic membrane filtration connected with pretreatment improves efficiency of filtration and recovery rate of physical cleaning. And ceramic membrane which is possible to operate in the higher flux than organic membrane can be reduce the area of water purification facilities and secure a stable quantity of water by connecting the ceramic membrane with pretreatment process.

• Korean Journal of Plant Resources
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• v.24 no.5
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• pp.613-621
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• 2011

Plastic house and laboratory experiments were conducted to determine the effects of substrate components and shade degrees on plant growth and physiologically-active substance content and antioxidant activity of Panax ginseng. No significant difference in growth characteristics among substrates was observed. However, shade treatment also significantly reduced leaf area, chlorophyll content, root length, and shoot and root fresh weight (P<0.05) with increasing of the degree. Total phenolics level [mg ferulic acid equivalents (FAE) $kg^{-1}$ DW] was higher in root parts (25.8 to 28.4 mg $kg^{-1}$) than shoot parts (20.7 to 23.8 mg $kg^{-1}$) of Panax ginseng, and with shade (23.7 to 28.4 mg $kg^{-1}$) than without shade (20.7 to 25.8 mg $kg^{-1}$). However, total flavonoids [mg naringin equivalents $kg^{-1}$ DW] was more detected in the shoot part (17.4 to 26.8 mg $kg^{-1}$) than in the root part (6.7 to 7.0 mg $kg^{-1}$) of Panax ginseng. Methanol extracts from the Panax ginseng plants dose-dependently increased DPPH free radical scavenging activity as a antioxidant potential, and the activity was higher in shoot parts (31.1 to 36.5%) than in root parts (24.9 to 28.7%), and without shade than with shade. In conclusion, shade affects plant growth as well as physiological activity of Panax ginseng under plastic house condition.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.28 no.2
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• pp.111-117
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• 2006

An area of current research is investigating the app1ication of human mesenchymal stem cells or hMSCs as a cell-based regenerative therapy. In order to achieve effective bone regeneration, appropriate matrices functioning as cell-carriers must be identified and optimized in terms of function, efficacy and biocompatibility. Two methods of approaching optimization of matrices are to facilitate adhesion of the donor hMSCs and furthermore to facilitate recruitment of host progenitor cells to osteoblastic differentiation. Pleiotrophin is an extracellular matrix protein that was first identified in developing rat brains and believed to be associated with developing neuronal pathways. A recent publication by Imai and colleagues demonstrated that transgenic mice with upregulated pleiotrophin expression developed a greater volume of cortical as well as cancellous bone. The proposed mechanism of action of pleiotrophin is demonstrated here. Through either environmental stresses and/or intracellular regulation, there is an increase in pleiotrophin production. The pleiotrophin is released extracellularly into areas requiring bone deposition. A receptor-mediated process recruits host osteoprogenitor cells into these areas. Therefore, the aim of our study was to investigate the osteoconductive properties of pleiotrophin. We wanted to determine if pleiotrophin coating facilitates cellular adhesion and furthermore if this has any effect on hMSCs derived bone formation in an animal model. The results showed a dose dependent response of cellular adhesion in fibronectin samples, and cellular adhesion was facilitated with increasing pleiotrophin concentrations. Histologic findings taken after 5 weeks implantation in SCID mouse showed no presence of bone formation with only a dense fibrous connective tissue. Possible explanations for the results of the osteogenesis assay include inappropriate cell loading.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.10
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• pp.4147-4152
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• 2014

Standard therapy for advanced head and neck cancer consists of a combination of surgery and radiation. However, survival of this patient population has not improved during the past 20 years. Many different multimodality treatment schedules have been proposed, and chemotherapy is often used with the intent of organ preservation. The present study was intended to establish the efficacy of concomitant chemoradiation with a single agent carboplatin in advanced head and neck cancers.The objectives were to investigate the feasibility of concomitant administration of carboplatin, monitor acute toxicity during radiotherapy, and determine subacute side effects, such as wound healing following surgery after chemoradiotherapy. A prospective study was conducted wherein a total of 40 patients with stage III and IV squamous cell carcinomas of oral cavity, oropharynx, hypopharynx and larynx were enrolled. All patients were treated with external beam radiotherapy and weekly carboplatin area under curve (AUC of 5). Radiotherapy was given in single daily fractions of 1.8-2 grays (Gy) to a total dose of 66-72 Gy. Salvage surgery was performed for any residual or recurrent locoregional disease. Neck dissection was recommended for all patients with neck disease showing less than a complete response after chemoradiation. A total of 40 patients were enrolled of whom 32 were males and 8 were females. Highest incidence of cancer was seen in the 5th-6th decades of life with a median age of 47.7 years. Oropharyngeal tumours constituted a maximum of 21 patients followed by hypopharynx in 10, larynx in 7 and oral cavity in 2. 80% of the patients had a neck node on presentation of which 40% had N2-N3 nodal status. TNM staging revealed that 58% of patients were in stage III and 43% in stage IV. Evaluation of acute toxicity revealed that 50% had grade II mucositis, 25% grade III mucositis, 2.5% grade IV mucositis. 50% of patients had grade I skin reactions, 65% of patients had grade I thrombocytopenia, and 24% of patients had grade I anaemia. After completion of treatment 65% of patients had complete response at the primary and regional sites, and 35% of patients had a partial response of whom 23% underwent neck dissection and 5% of them underwent salvage surgery at the primary site. At the end of one year there were six deaths and four recurrences and 70% were free of disease. Concurrent chemoradiation with carboplatin provided good locoregional control for locally advanced head and neck cancers. This regimen, although toxic, is tolerable with appropriate supportive intervention. Primary site conservation is possible in many patients. Chemoradiotherapy appears to have an emerging role in the primary management of head and neck cancers.

• Korean Parent-Child Health Journal
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• v.6 no.1
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• pp.70-81
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• 2003

The otitis media has the highest rate of occurrence in 6-36 month after birth, and relatively high rate of occurrence to six years old. It is one of major cause for hearing loss problem because of its high rate of recurrence. The researcher observed at bed that feeding posture and feeding habit at night have some relationship with occurrence of otitis media. I found that medical research in this area was very weak, and it caused her to concentrate her research on the topic. This paper was undertook a retrospective case-control study to find out the relationship between the mode of feeding and the occurrence of otitis media among the otitis media patients and the healthy persons. As the controling groups, the researcher chose fifty eight mothers whose children received the treatment of otitis media(6-36 months after birth) from the pediatrics clinic of two general hospitals in Seoul, as the patient group, and forty five mothers who consulted with their child to well baby clinic at the general hospital and kindergarten in Seoul as the control group. The results of the survey can be summarized as followed : 1. "Otitis media patient group may have more lying posture mothers while feeding than the healthy control group". The first hypothesis is supported by the fact that the children who have lying posture feeding habit mothers are more easily exposed to otitis media than those who have sitting posture feeding habit mothers as the analysis show : $X^2=8.142$, p = .017 2. "Otitis media patient group may have higher rate of sleeping habit with milk bottle on the month at night than the healthy control group does". The second hypothesis was supported by the fact that the patients group has higher rate of expected sleeping habit than the healthy group dose as the analysis show : $X^2=4.35$, p = .037 3. "Otitis media can be found more in the artificial feeding group than in the healthy children group". The hypothesis is rejected by the analysis, $X^2=1.550$, p = .416. Though the hypothesis is not supported by this research, we need to encourage mothers to feed mother's breast milk on the ground that healthy group has mother's milk feeding tendency, and the best food for infants is their mother's milk, and psychological-sociological effects of breast feeding os quite good for children. It will improve the health of infants. It can be summarized as follows : Otitis media is more concerned with posture of feeding and night feeding habits than feeding modes. On the basis of this survey, feeding education problem for mothers of infants need to be developed. In the education, sitting-embracing posture of feeding, mother's breast feeding, and prohibition of children's lying posture feeding at night need to be emphasized.